WO2022059317A1 - 遠心式血液ポンプ - Google Patents

遠心式血液ポンプ Download PDF

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Publication number
WO2022059317A1
WO2022059317A1 PCT/JP2021/026238 JP2021026238W WO2022059317A1 WO 2022059317 A1 WO2022059317 A1 WO 2022059317A1 JP 2021026238 W JP2021026238 W JP 2021026238W WO 2022059317 A1 WO2022059317 A1 WO 2022059317A1
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WO
WIPO (PCT)
Prior art keywords
blood
impeller
top shroud
magnetic
radial direction
Prior art date
Application number
PCT/JP2021/026238
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
太基 宮村
Original Assignee
株式会社ジェイ・エム・エス
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社ジェイ・エム・エス filed Critical 株式会社ジェイ・エム・エス
Priority to EP21869004.8A priority Critical patent/EP4215753A1/en
Priority to CN202180061958.XA priority patent/CN116249835A/zh
Publication of WO2022059317A1 publication Critical patent/WO2022059317A1/ja

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/226—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly radial components
    • A61M60/232—Centrifugal pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/109—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body incorporated within extracorporeal blood circuits or systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/221—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having both radial and axial components, e.g. mixed flow pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/30—Medical purposes thereof other than the enhancement of the cardiac output
    • A61M60/36—Medical purposes thereof other than the enhancement of the cardiac output for specific blood treatment; for specific therapy
    • A61M60/38—Blood oxygenation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/419—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818—Bearings
    • A61M60/824—Hydrodynamic or fluid film bearings
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D13/00—Pumping installations or systems
    • F04D13/02—Units comprising pumps and their driving means
    • F04D13/021—Units comprising pumps and their driving means containing a coupling
    • F04D13/024—Units comprising pumps and their driving means containing a coupling a magnetic coupling
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D29/00—Details, component parts, or accessories
    • F04D29/04—Shafts or bearings, or assemblies thereof
    • F04D29/041—Axial thrust balancing
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04D—NON-POSITIVE-DISPLACEMENT PUMPS
    • F04D29/00—Details, component parts, or accessories
    • F04D29/08—Sealings
    • F04D29/16—Sealings between pressure and suction sides
    • F04D29/165—Sealings between pressure and suction sides especially adapted for liquid pumps
    • F04D29/167—Sealings between pressure and suction sides especially adapted for liquid pumps of a centrifugal flow wheel

Definitions

  • the present invention relates to a centrifugal blood pump.
  • an extracorporeal blood circulation circuit such as an artificial heart-lung machine is used to temporarily replace the cardiopulmonary function of a patient.
  • the extracorporeal blood circulation circuit comprises a blood pump for flowing blood through the circuit.
  • a centrifugal blood pump is known in which an impeller (impeller) is rotated in a pump chamber (blood accommodating portion) to give centrifugal force to blood to send liquid.
  • a thrombus may be formed in the centrifugal blood pump.
  • the formation of blood clots impairs blood flow and can lead to poor performance of centrifugal blood pumps.
  • a structure in which an impeller pivoted to an upper bearing and a lower bearing is rotatably arranged is disclosed in a housing (see, for example, Patent Document 1).
  • the housing of the centrifugal blood pump described in Patent Document 1 is provided with an inlet port arranged at an upper portion and an outlet port arranged at a side portion. Blood flowing into the housing from the inlet port passes through the upper bearing of the impeller, receives centrifugal force due to the rotation of the impeller, and is swept outward in the radial direction. Blood that has been flushed outward in the radial direction is drained out of the housing through the outlet port.
  • the impeller is pivotally supported by the upper bearing and the lower bearing, and the blood flowing into the housing from the inlet port stays in the upper bearing portion to form a thrombus. Can be formed. Therefore, it is desired to be able to suppress the formation of thrombus.
  • An object of the present invention is to provide a centrifugal blood pump capable of suppressing the formation of a thrombus.
  • the present invention has a blood accommodating portion having an upper surface portion, a lower surface portion, and a side surface portion and accommodating blood, an inlet port formed in communication with the blood accommodating portion and opening upward, and the blood accommodating portion.
  • a top shroud having a blood introduction opening, a plurality of guide portions formed between the base and the top shroud to guide blood introduced from the blood introduction opening toward the outside in the radial direction, and a lower end portion.
  • An impeller having a rotating shaft member pivotally supported on the lower surface of the housing and rotatable about a rotating shaft, and a first magnetic material arranged in the lower part of the base, and arranged below the blood containing portion.
  • It is a magnetic driving unit that has a second magnetic body that is arranged below the first magnetic body and is bonded by magnetic coupling with the first magnetic body, and has the first magnetic body and the second magnetic body.
  • It is provided with a magnetic drive unit that rotationally drives the impeller around the rotation axis in a state of being magnetically coupled by a magnetic coupling force that acts to attract the body in the vertical direction, and includes an upper surface of the top shroud and the blood.
  • the lower surface of the upper surface of the accommodating portion relates to a centrifugal blood pump formed so as to narrow from the outer side to the inner side in the radial direction of the top shroud.
  • the upper surface of the top shroud is formed in a straight line that is inclined downward from the inside to the outside in the radial direction, and the lower surface of the upper surface portion of the blood storage portion is formed from the inside to the outside in the radial direction. It is preferably formed in a straight line that slopes downward.
  • the angle difference between the upper surface of the top shroud and the lower surface of the upper surface portion of the blood storage portion is preferably 2.5 to 4.0 °.
  • the lower surface of the impeller and the upper surface of the lower surface portion of the blood storage portion are arranged in parallel.
  • centrifugal blood pump capable of suppressing the formation of a thrombus.
  • FIG. 3 is a cross-sectional view taken along the line AA of FIG. It is a perspective view which looked at the impeller of a centrifugal blood pump from the upper side. It is a perspective view which looked at the impeller of a centrifugal blood pump from the lower side.
  • the centrifugal blood pump 1 of the present invention is a blood pump that circulates blood used in an extracorporeal blood circulation circuit such as an artificial heart-lung machine.
  • the centrifugal blood pump 1 includes a housing 10, an impeller 20 (impeller) housed inside the housing 10, and a drive device 30 (magnetic drive unit).
  • the impeller 20 can rotate about the rotation axis J in the pump chamber 11 by the driving force of the driving device 30.
  • the housing 10 has a pump chamber 11 (blood accommodating portion), an inlet port 17, and an outlet port 18.
  • the inlet port 17 and the outlet port 18 communicate with the inside of the pump chamber 11.
  • the impeller 20 is housed in the pump chamber 11, and the blood supplied from the inlet port 17 is temporarily housed.
  • the blood contained in the pump chamber 11 is discharged to the outside through the outlet port 18 by centrifugal force when the impeller 20 is rotated.
  • the pump chamber 11 has an upper surface portion 12, a lower surface portion 13, a peripheral wall portion 14 (side surface portion), and a lower bearing 15.
  • the upper surface portion 12 is arranged above the pump chamber 11 as shown in FIG.
  • the upper surface portion 12 is formed in an annular plate shape, and is inclined downward from the inside to the outside in the radial direction.
  • the lower surface 121 of the upper surface portion 12 is formed in a linear shape that is inclined downward from the inside to the outside in the radial direction.
  • the inlet port 17 is connected to the upper part of the central part of the upper surface part 12.
  • the inlet port 17 is formed so as to communicate with the inside of the pump chamber 11 and opens upward.
  • the inlet port 17 extends upward from the upper part of the pump chamber 11 in the same direction as the rotation shaft J of the rotation shaft member 21.
  • the lower surface portion 13 is arranged below the upper surface portion 12 at a distance.
  • the lower surface portion 13 has a central convex portion 131 formed in the center and projecting upward, and an annular inclined portion 132 formed in an annular shape on the outer side of the central convex portion 131.
  • the lower bearing 15 is arranged in the radial center of the central convex portion 131.
  • the lower end portion 211 of the rotary shaft member 21 of the impeller 20, which will be described later, is inserted into the lower bearing 15.
  • the lower bearing 15 rotatably supports the lower end portion 211 of the rotary shaft member 21 around the rotary shaft J.
  • the annular inclined portion 132 is formed in a downwardly inclined annular shape from the inside to the outside in the radial direction.
  • the upper surface 132a of the annular inclined portion 132 is formed in a linear shape in which the lower surface portion 13 is inclined downward from the inside to the outside in the radial direction.
  • the peripheral wall portion 14 constitutes the peripheral wall of the pump chamber 11 and is formed in the shape of a cylindrical wall extending downward from the radial outer end portion of the upper surface portion 12.
  • the peripheral wall portion 14 has an upper peripheral wall portion 141 and a lower peripheral wall portion 142.
  • the upper peripheral wall portion 141 extends in the vertical direction by connecting the radial end portion of the upper surface portion 12 and the circumferential end portion of the lower surface portion 13.
  • the inner surface of the upper peripheral wall portion 141 is formed by being recessed in an arc shape on the outer side in the radial direction on the upper side, and is formed so as to be inclined downward from the outer side in the radial direction to the inner side on the lower side.
  • an exit port 18 is connected to the outer surface of the upper peripheral wall portion 141.
  • the outlet port 18 is formed so as to communicate with the inside of the pump chamber 11 and opens toward the side.
  • the outlet port 18 extends horizontally along the tangent line of the circle centered on the rotation axis J of the rotation axis member 21 in the upper peripheral wall portion 141 of the pump chamber 11.
  • the lower peripheral wall portion 142 extends downward from the lower end of the upper peripheral wall portion 141.
  • the lower peripheral wall portion 142 is formed in a cylindrical shape thicker than the thickness of the upper peripheral wall portion 141.
  • a rotor 31 of a drive device 30, which will be described later, is arranged inside the lower peripheral wall portion 142.
  • the impeller 20 is rotatably arranged around the rotation axis J inside the pump chamber 11 of the housing 10.
  • the impeller 20 includes a rotary shaft member 21 that can rotate around the rotary shaft J, an impeller main body 22 connected to the rotary shaft member 21, and a plurality of impeller side magnets 27 (No. 1). 1 magnetic material) and.
  • the impeller main body 22 has a base 23, a top shroud 24, a plurality of vanes 25 (guide members) (first vanes 251 and second vanes 252), and a shaft connecting portion 253.
  • the base 23 is arranged at the bottom of the impeller body 22.
  • the base 23 has a horizontal upper surface plate 231, an inclined face plate 232, and an annular convex portion 233.
  • the horizontal top plate 231 is formed in a horizontal annular shape at the center in the radial direction.
  • a through hole 231a penetrating in the vertical direction is formed at the center of the horizontal top plate 231 in the radial direction.
  • a rotary shaft member 21 is arranged through the through hole 231a.
  • the inclined face plate 232 is formed in an annular shape that is inclined downward from the radial outer end portion of the horizontal upper surface plate 231 toward the radial outer side.
  • the annular convex portion 233 extends in an annular shape along the circumferential direction of the base 23 and protrudes downward at the lower portion of the radial outer end portion of the inclined face plate 232.
  • the annular convex portion 233 is formed so as to be inclined downward from the inside to the outside in the radial direction of the base 23.
  • the lower surface 233a of the annular convex portion 233 is formed in a linear shape that is inclined downward from the inside to the outside in the radial direction of the base 23. As shown in FIG. 2, the lower surface 233a of the annular convex portion 233 is arranged parallel to the upper surface 132a of the annular inclined portion 132.
  • a plurality of impeller-side magnets 27 are arranged inside the annulus convex portion 233.
  • the plurality of impeller-side magnets 27 are arranged at equal intervals along the circumferential direction of the base 23 at the lower portion on the outer side in the radial direction of the base 23.
  • the plurality of impeller-side magnets 27 are each formed in a columnar shape having an axial length shorter than the diameter, and the upper surface and the lower surface are arranged so as to be inclined downward from the inside to the outside in the radial direction of the base 23. Will be done.
  • the top shroud 24 is arranged facing the base 23 at a position separated above the base 23.
  • the top shroud 24 is formed in a plate-shaped annular shape.
  • the top shroud 24 is inclined downward from the inside to the outside in the radial direction.
  • the upper surface 242 of the top shroud 24 is formed in a linear shape that is inclined downward from the inside to the outside in the radial direction.
  • a circular blood introduction opening 241 that penetrates the top shroud 24 in the vertical direction is formed.
  • the upper portion of the rotary shaft member 21 is arranged through the blood introduction opening 241 so that the blood supplied from the inlet port 17 to the pump chamber 11 flows through the blood introduction opening 241.
  • the outer diameter of the top shroud 24 is formed to be substantially the same as the outer diameter of the upper surface of the base 23.
  • the gap S1 between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is formed by a downward slope that descends from the inside to the outside in the radial direction of the top shroud 24, and is formed from the inside in the radial direction. It is formed to spread toward the outside.
  • the gap S1 between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is formed so as to narrow from the outside to the inside in the radial direction of the top shroud 24.
  • the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is preferably 2.5 to 4.0 °, and preferably 3.0 to 3.5 °. More preferred. In the present embodiment, the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is set to 3.0 °. The reason why the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is preferably 2.5 to 4.0 ° will be described later.
  • the plurality of vanes 25 are arranged between the base 23 and the top shroud 24 as shown in FIGS. 2 to 4. Each of the plurality of vanes 25 extends in the vertical direction so as to connect the base 23 and the top shroud 24, and is formed in a plate shape extending in the radial direction. The plurality of vanes 25 guide the blood introduced from the blood introduction opening 241 of the top shroud 24 outward in the radial direction. In the present embodiment, the plurality of vanes 25 are three first vanes 251 and three second vanes 252.
  • the first vane 251 and the second vane 252 are alternately arranged at equal intervals in the circumferential direction of the top shroud 24.
  • the lower edge of the first vane 251 and the second vane 252 is fixed to the upper surface of the base 23.
  • the upper edge of the first vane 251 and the second vane 252 is fixed to the lower surface of the top shroud 24.
  • the base 23 and the top shroud 24 are integrated via the first vane 251 and the second vane 252.
  • the radial outer ends of the first vane 251 and the second vane 252 extend radially to approximately the same position as the outer ends of the base 23 and top shroud 24.
  • the radial inner ends of each of the three first vanes 251 are connected to a shaft connecting portion 253 located in the center of the radial direction.
  • a rotary shaft member 21 extending in the vertical direction is connected to the shaft connecting portion 253 connecting the inner ends of each of the three first vanes 251 in a state of penetrating.
  • the radial inner ends of each of the three second vanes 252 are not connected to the rotary shaft member 21 and are in substantially the same position as the outer ends of the blood introduction opening 241 of the top shroud 24 in the radial direction. Extends to.
  • the space between the base 23 and the top shroud 24 arranged so as to face each other vertically is divided into six in the circumferential direction by the first vane 251 and the second vane 252 adjacent to each other in the circumferential direction. Ru.
  • six taxiways 26 are formed between the base 23 and the top shroud 24.
  • the six taxiways 26 extend radially along the radial direction from the center of the impeller 20.
  • the upper side communicates with the blood introduction opening 241 formed in the radial center of the top shroud 24, and the lower side communicates with the radial center of the base 23. Communicate with hole 231a.
  • the taxiway 26 opens radially outward at the radial outer end of the impeller 20.
  • the taxiway 26 guides the blood introduced from the blood introduction opening 241 between the base 23 and the top shroud 24 radially outward.
  • the rotary shaft member 21 is arranged so as to penetrate the radial center portion of the top shroud 24 in the vertical direction and extends in the vertical direction.
  • the rotary shaft member 21 is connected to the shaft connecting portion 253 in a state of penetrating the shaft connecting portion 253 connecting the inner ends of the three first vanes 251.
  • the lower end portion 211 of the rotating shaft member 21 is pivotally supported by a lower bearing 15 arranged on the lower surface portion 13 of the housing 10.
  • the lower bearing 15 is provided in the center of the lower surface portion 13 of the pump chamber 11.
  • the centrifugal blood pump 1 of the present embodiment includes a so-called monopivot bearing structure in which the impeller 20 is supported by only one point of the lower bearing 15.
  • the upper end portion 212 of the rotary shaft member 21 is not supported by the bearing, blood is less likely to stay at the upper end portion 212 of the rotary shaft member 21, and blood stagnation is reduced. Therefore, a thrombus is unlikely to be formed in the vicinity of the upper end portion 212.
  • the drive device 30 is arranged below the housing 10.
  • the drive device 30 includes a rotor 31 and a drive shaft 32 capable of rotating the rotor 31 around the rotation shaft J.
  • the drive shaft 32 extends from the lower surface of the rotor 31 as much as possible.
  • the drive shaft 32 is connected to a rotary drive source such as a motor and is rotationally driven.
  • the rotor 31 has a truncated cone 311 and a plurality of drive-side magnets 312 (second magnetic material) arranged on the upper surface of the truncated cone 311.
  • the plurality of drive-side magnets 312 are arranged below the impeller-side magnets 27, facing the plurality of impeller-side magnets 27 of the impeller 20 housed inside the housing 10, below the housing 10.
  • the plurality of drive-side magnets 312 are arranged in the same number as the impeller-side magnets 27, and are arranged at equal intervals in the circumferential direction of the truncated cone 311.
  • Each of the plurality of drive-side magnets 312 is formed in a columnar shape having an axial length shorter than the diameter, and the upper surface and the lower surface are inclined so as to descend from the inside to the outside in the radial direction of the truncated cone 311. Be placed.
  • the drive device 30 rotates in a state of being magnetically coupled by a magnetic coupling force that acts to attract the impeller side magnet 27 and the drive side magnet 312 in the vertical direction.
  • the impeller 20 is rotationally driven around the axis J.
  • the magnetic coupling force between the impeller side magnet 27 and the drive side magnet 312 is 12N.
  • the blood introduced into the six taxiways 26 receives centrifugal force due to the rotation of the impeller 20 and moves from the inside to the outside in the taxiway 26 in the radial direction to the outside in the radial direction of the taxiway 26. It is discharged from the end of the pump chamber 11 to the outside through the outlet port 18.
  • the blood flowing out from the radial outer end of the guideway 26 to the pump chamber 11 is between the lower surface 233a of the annular convex portion 233 of the base 23 and the upper surface 132a of the lower surface portion 13 of the pump chamber 11. It is moved to the through hole 231a side of the base 23 through the gap S2.
  • the blood transferred to the through hole 231a side through the gap S2 below the base 23 is introduced into the taxiway 26 through the through hole 231a of the base 23. Therefore, a blood flow (so-called secondary flow) that moves on the lower side of the base 23 and returns to the through hole 231a of the base 23 occurs.
  • secondary flow that moves on the lower side of the base 23 and returns to the through hole 231a of the base 23 occurs.
  • a force that pushes up the impeller 20 is generated.
  • the blood flowing out from the radial outer end of the guide path 26 to the pump chamber 11 passes through the gap S1 between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11. , Moved to the blood introduction opening 241 side.
  • the blood transferred to the blood introduction opening 241 side through the gap S1 above the top shroud 24 is introduced into the taxiway 26 through the blood introduction opening 241 of the top shroud 24.
  • the gap S1 is formed so as to narrow from the outer side in the radial direction of the top shroud 24 toward the inner side.
  • An angle difference ⁇ is provided between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11. Therefore, the blood passing through the gap S1 between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 creates a pressure to push the top shroud 24 downward from above.
  • the pressure of blood passing through the gap S1 pushes the impeller 20 downward, and the ascent of the impeller 20 is suppressed.
  • the upper surface 242 of the top shroud 24, the lower surface 121 of the upper surface portion 12 of the pump chamber 11, and the angle difference ⁇ will be described.
  • the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 will be described from the viewpoint of suppressing the ascent of the impeller 20 and from the viewpoint of hemolytic resistance.
  • the upper end portion 212 is not pivotally supported, but the lower end portion 211 is pivotally supported.
  • blood does not easily stay in the upper end 212 of the rotary shaft member 21, and a thrombus is less likely to be formed in the vicinity of the upper end 212.
  • the impeller 20 is centered on the rotation axis J by driving the drive device 30 in a state where the impeller side magnet 27 and the drive side magnet 312 are magnetically coupled by a magnetic coupling force that acts to attract each other in the vertical direction. Rotate to.
  • the impeller 20 the lower end portion 211 of the rotary shaft member 21 is pivotally supported, whereas the upper end portion 212 is not pivotally supported. Further, the blood flowing through the gap S2 between the lower surface 233a of the annular convex portion 233 of the base 23 and the upper surface 132a of the lower surface portion 13 of the pump chamber 11 pushes up the impeller 20. Therefore, even if the impeller side magnet 27 and the drive side magnet 312 are magnetically coupled by a magnetic coupling force, between the lower surface 233a of the annular convex portion 233 of the base 23 and the upper surface 132a of the lower surface portion 13 of the pump chamber 11. When the blood flowing through the gap S2 pushes up the impeller 20, the impeller 20 may rise and fall off from the lower bearing 15.
  • the clearance of the gap S1 is in the radial direction of the top shroud 24. It is formed smaller from the outside to the inside.
  • the pressure of blood flowing through the gap S1 between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 pushes the impeller 20 downward from the upper side of the impeller 20 to push the impeller 20 downward. Buoyancy can be suppressed.
  • the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is increased, the shearing force acting on the blood increases.
  • blood cells may be destroyed (hemolysis) and hemolytic resistance may not be ensured. Therefore, hemolytic resistance is ensured by setting the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 to such an angle difference that the shearing force does not become too large. Is required.
  • the judgment criteria that can suppress the ascent of the impeller 20 are set as follows.
  • the impeller 20 is rotated in a state where a magnetic coupling force acting to attract the rotor 31 of the drive device 30 in the vertical direction is magnetically coupled at 12N.
  • the force that pushes up the impeller 20 generated by the secondary flow of blood and the rotor 31 of the impeller 20 and the drive device 30 Experiments have shown that the maximum levitation force of the impeller 20 is preferably 8N or less, taking into account the magnetic coupling force that acts to attract the impeller in the vertical direction and the safety factor. There is.
  • the maximum levitation force of the impeller 20 is 8N when the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is changed. If it is the following, it is judged as OK (" ⁇ " judgment).
  • the criteria for determining hemolytic resistance are set as follows. Experiments have shown that hemolytic resistance is ensured when the shear force is 900 Pa or less. Therefore, as a criterion for determining hemolytic resistance, it is OK when the shearing force is 900 Pa or less when the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is changed. Judgment (“ ⁇ ” judgment).
  • the levitation force of the impeller 20 when the maximum levitation force of the impeller 20 is 8N or less, it is evaluated as “ ⁇ ”, and when the maximum levitation force of the impeller 20 is larger than 8N, it is evaluated as “x”.
  • the hemolytic resistance when the shearing force was 900 Pa or less, it was evaluated as “ ⁇ ”, and when the shearing force was larger than 900 Pa, it was evaluated as “x”.
  • the impeller 20 floats when the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is 2.5 to 4.0 °.
  • the judgment result regarding the force and hemolytic resistance is " ⁇ ”, both judgment criteria are satisfied, and the comprehensive judgment is " ⁇ ". Therefore, the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is preferably 2.5 to 4.0 °.
  • the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is 3.0 to 3.5, which is a value on the center side in the range of 2.5 to 4.0 °. It is more preferably °. In the present embodiment, the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is set to 3.0 °.
  • Centrifugal blood pump 1 was introduced from the housing 10, a top shroud 24 having a blood introduction opening 241 disposed inside the housing 10 and formed radially in the center, and a blood introduction opening 241.
  • the impeller 20 having a plurality of impeller side magnets 27 arranged at the bottom, and the impeller side magnet 27 and the drive side magnet 312 rotate in a state of being magnetically coupled by a magnetic coupling force acting to attract each other in the vertical direction.
  • a magnetic drive unit 30 for rotationally driving the impeller 20 around the shaft J is provided, and the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 are provided in the radial direction of the top shroud 24. It was formed so as to narrow from the outside to the inside.
  • the upper end portion 212 of the rotary shaft member 21 is not supported by the bearing, so that it is difficult to form a blood clot, and the upper end portion 212 of the rotary shaft member 21 is not supported by the bearing.
  • the impeller 20 is pushed downward. , The pressure of blood can be applied from the upper side to the lower side of the impeller 20. As a result, the formation of a thrombus can be suppressed, the ascent of the impeller 20 can be suppressed, and the impeller 20 can be stably rotated.
  • the upper surface 242 of the top shroud 24 is formed in a straight line inclined downward from the inside to the outside in the radial direction, and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is directed from the inside to the outside in the radial direction. It was formed into a straight line that slopes downward. As a result, the gap S1 between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 is gradually narrowed, so that the pressure of blood that pushes the impeller 20 downward is stably suppressed. It can be generated and the impeller 20 can be rotated more stably.
  • the angle difference ⁇ between the upper surface 242 of the top shroud 24 and the lower surface 121 of the upper surface portion 12 of the pump chamber 11 was set to 2.5 to 4.0 °. As a result, hemolytic resistance can be ensured while suppressing the levitation force of the impeller 20.
  • the lower surface 233a of the annular convex portion 233 of the impeller 20 and the upper surface 132a of the annular inclined portion 132 of the lower surface portion 13 of the pump chamber 11 are arranged in parallel. As a result, since the pressure of the blood flowing through the gap S2 is constant, the impeller 20 can be rotated stably.
  • the present invention is not limited to the above-described embodiment and can be appropriately modified.
  • the rotary shaft member 21 is arranged so as to penetrate the radial center portion of the top shroud 24 in the vertical direction, but the present invention is not limited to this. Since the upper end portion of the rotary shaft member 21 is not pivotally supported, the upper end portion side of the rotary shaft member 21 does not have to penetrate the top shroud 24.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Fluid Mechanics (AREA)
  • Emergency Medicine (AREA)
  • Structures Of Non-Positive Displacement Pumps (AREA)
  • External Artificial Organs (AREA)
PCT/JP2021/026238 2020-09-16 2021-07-13 遠心式血液ポンプ WO2022059317A1 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP21869004.8A EP4215753A1 (en) 2020-09-16 2021-07-13 Centrifugal blood pump
CN202180061958.XA CN116249835A (zh) 2020-09-16 2021-07-13 离心式血液泵

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JP2020-155132 2020-09-16
JP2020155132A JP2022049096A (ja) 2020-09-16 2020-09-16 遠心式血液ポンプ

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115837118A (zh) * 2022-11-01 2023-03-24 北京航空航天大学 一种磁耦合驱动的离心式血泵

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05212112A (ja) * 1992-02-03 1993-08-24 Terumo Corp 血液ポンプ
WO2012115155A1 (ja) * 2011-02-24 2012-08-30 株式会社ジェイ・エム・エス ターボ式血液ポンプ
JP2012193658A (ja) 2011-03-16 2012-10-11 Jms Co Ltd ターボ式血液ポンプ及びその製造方法
JP2018061600A (ja) * 2016-10-11 2018-04-19 株式会社ジェイ・エム・エス 遠心式血液ポンプ

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05212112A (ja) * 1992-02-03 1993-08-24 Terumo Corp 血液ポンプ
WO2012115155A1 (ja) * 2011-02-24 2012-08-30 株式会社ジェイ・エム・エス ターボ式血液ポンプ
JP2012193658A (ja) 2011-03-16 2012-10-11 Jms Co Ltd ターボ式血液ポンプ及びその製造方法
JP2018061600A (ja) * 2016-10-11 2018-04-19 株式会社ジェイ・エム・エス 遠心式血液ポンプ

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115837118A (zh) * 2022-11-01 2023-03-24 北京航空航天大学 一种磁耦合驱动的离心式血泵

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JP2022049096A (ja) 2022-03-29
CN116249835A (zh) 2023-06-09

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